Trial Outcomes & Findings for Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years. (NCT NCT00326118)
NCT ID: NCT00326118
Last Updated: 2018-08-24
Results Overview
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
433 participants
Primary outcome timeframe
1 month after vaccination
Results posted on
2018-08-24
Participant Flow
Total of subjects completed in the previous period does not necessarily correspond to the amount of subjects who came back for the follow-up. These subjects were considered lost-to-follow-up.
Participant milestones
| Measure |
Menitorix Group
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Active Phase
STARTED
|
324
|
109
|
|
Active Phase
COMPLETED
|
320
|
108
|
|
Active Phase
NOT COMPLETED
|
4
|
1
|
|
Year 1 Follow-up
STARTED
|
295
|
100
|
|
Year 1 Follow-up
COMPLETED
|
295
|
100
|
|
Year 1 Follow-up
NOT COMPLETED
|
0
|
0
|
|
Year 2 Follow-up
STARTED
|
270
|
92
|
|
Year 2 Follow-up
COMPLETED
|
270
|
92
|
|
Year 2 Follow-up
NOT COMPLETED
|
0
|
0
|
|
Year 3 Follow-up
STARTED
|
256
|
89
|
|
Year 3 Follow-up
COMPLETED
|
256
|
89
|
|
Year 3 Follow-up
NOT COMPLETED
|
0
|
0
|
|
Year 4 Follow-up
STARTED
|
228
|
80
|
|
Year 4 Follow-up
COMPLETED
|
228
|
80
|
|
Year 4 Follow-up
NOT COMPLETED
|
0
|
0
|
|
Year 5 Follow up
STARTED
|
217
|
78
|
|
Year 5 Follow up
COMPLETED
|
217
|
78
|
|
Year 5 Follow up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Menitorix Group
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Active Phase
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Baseline characteristics by cohort
| Measure |
Menitorix Group
n=324 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=109 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Total
n=433 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.5 Months
STANDARD_DEVIATION 0.94 • n=5 Participants
|
12.5 Months
STANDARD_DEVIATION 0.75 • n=7 Participants
|
12.5 Months
STANDARD_DEVIATION 0.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
Outcome measures
| Measure |
Menitorix Group
n=292 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=100 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
|
292 Subjects
|
100 Subjects
|
PRIMARY outcome
Timeframe: 1 month after vaccinationPopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
Outcome measures
| Measure |
Menitorix Group
n=281 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=98 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
|
280 Subjects
|
98 Subjects
|
SECONDARY outcome
Timeframe: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=281 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=98 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:128 [1 year after vaccination] (N=249, 89)
|
117 Subjects
|
37 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:128 [4 years after vaccination] (N= 208, 73)
|
7 Subjects
|
4 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:8 [1 year after vaccination] (N=249, 89)
|
216 Subjects
|
68 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:8 [2 years after vaccination] (N= 235, 86)
|
164 Subjects
|
52 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:8 [3 years after vaccination] (N= 226, 77)
|
145 Subjects
|
41 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:8 [4 years after vaccination] (N= 208, 73)
|
26 Subjects
|
9 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:128 [Prior to vaccination] (N=255, 83)
|
15 Subjects
|
3 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:128 [1 month after vaccination] (N=281, 98)
|
247 Subjects
|
89 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:128 [2 years after vaccination] (N= 235, 86)
|
76 Subjects
|
26 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:128 [3 years after vaccination] (N= 226, 77)
|
58 Subjects
|
22 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:8 [Prior to vaccination] (N=255, 83)
|
37 Subjects
|
7 Subjects
|
SECONDARY outcome
Timeframe: 5 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=195 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=68 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:8 [5 years after vaccination]
|
37 Subjects
|
17 Subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
≥ 1:128 [5 years after vaccination ]
|
12 Subjects
|
7 Subjects
|
SECONDARY outcome
Timeframe: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=281 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=98 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Prior to vaccination (N= 255; 83)
|
6.3 Titer
Interval 5.5 to 7.3
|
5.5 Titer
Interval 4.3 to 7.2
|
|
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
1 month after vaccination (N= 281; 98)
|
482.8 Titer
Interval 420.7 to 554.2
|
621.0 Titer
Interval 480.3 to 802.9
|
|
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
4 years after vaccination (N=208;73)
|
5.3 Titer
Interval 4.7 to 6.0
|
6.0 Titer
Interval 4.5 to 8.0
|
|
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
1 year after vaccination (N= 249; 89)
|
91.7 Titer
Interval 75.6 to 111.3
|
63.8 Titer
Interval 43.3 to 94.1
|
|
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
2 years after vaccination (N= 235; 86)
|
39.3 Titer
Interval 31.3 to 49.3
|
30.6 Titer
Interval 20.1 to 46.7
|
|
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
3 years after vaccination (N= 226; 77)
|
29.8 Titer
Interval 23.6 to 37.6
|
21.8 Titer
Interval 14.2 to 33.5
|
SECONDARY outcome
Timeframe: 5 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=195 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=68 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
|
6.6 Titer
Interval 5.6 to 7.8
|
8.5 Titer
Interval 5.9 to 12.3
|
SECONDARY outcome
Timeframe: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Outcome measures
| Measure |
Menitorix Group
n=292 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=100 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 0.15 µg/mL [Prior to vaccination] (N=285,98)
|
219 Subjects
|
82 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 0.15 µg/mL [1 year post-vaccination] (N=255,91)
|
252 Subjects
|
91 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 0.15 µg/mL [2 years post-vaccination] (N=237,84)
|
235 Subjects
|
84 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 1.0 µg/mL [1 year post-vaccination] (N=255,91)
|
209 Subjects
|
80 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 1.0 µg/mL [2 years post-vaccination] (N=237,84)
|
174 Subjects
|
72 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 1.0 µg/mL [3 years post-vaccination] (N=233,78)
|
164 Subjects
|
64 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 1.0 µg/mL [4 years post-vaccination] (N=204,73)
|
144 Subjects
|
57 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 0.15 µg/mL [3 years post-vaccination] (N=233,78)
|
231 Subjects
|
77 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 0.15 µg/mL [4 years post-vaccination] (N=204,73)
|
202 Subjects
|
73 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 1.0 µg/mL [Prior to vaccination] (N=285,98)
|
77 Subjects
|
22 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 1.0 µg/mL [1 month post-vaccination] (N=292,100)
|
286 Subjects
|
100 Subjects
|
SECONDARY outcome
Timeframe: 5 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Outcome measures
| Measure |
Menitorix Group
n=191 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=67 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 0.15 µg/mL [5 years post-vaccination]
|
191 Subjects
|
67 Subjects
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
≥ 1.0 µg/mL [5 years post-vaccination]
|
129 Subjects
|
47 Subjects
|
SECONDARY outcome
Timeframe: Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Menitorix Group
n=292 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=100 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Prior to vaccination (N=285, 98)
|
0.438 microgram per milliliter (µg/mL)
Interval 0.374 to 0.512
|
0.472 microgram per milliliter (µg/mL)
Interval 0.364 to 0.611
|
|
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
3 years after vaccination (N= 233, 78)
|
2.234 microgram per milliliter (µg/mL)
Interval 1.886 to 2.647
|
2.751 microgram per milliliter (µg/mL)
Interval 2.113 to 3.582
|
|
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
1 month after vaccination (N=292, 100)
|
46.652 microgram per milliliter (µg/mL)
Interval 38.929 to 55.907
|
73.976 microgram per milliliter (µg/mL)
Interval 57.624 to 94.968
|
|
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
1 year after vaccination (N=255, 91)
|
3.550 microgram per milliliter (µg/mL)
Interval 2.988 to 4.218
|
4.802 microgram per milliliter (µg/mL)
Interval 3.708 to 6.218
|
|
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
2 years after vaccination (N= 237, 84)
|
2.5 microgram per milliliter (µg/mL)
Interval 2.1 to 3.0
|
3.3 microgram per milliliter (µg/mL)
Interval 2.5 to 4.2
|
|
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
4 years after vaccination (N= 204, 73)
|
2.116 microgram per milliliter (µg/mL)
Interval 1.773 to 2.524
|
2.964 microgram per milliliter (µg/mL)
Interval 2.215 to 3.966
|
SECONDARY outcome
Timeframe: 5 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Menitorix Group
n=191 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=67 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
|
2.131 microgram per milliliter (µg/mL)
Interval 1.752 to 2.592
|
2.537 microgram per milliliter (µg/mL)
Interval 1.815 to 3.546
|
SECONDARY outcome
Timeframe: Prior to, 1 month, 1 year, 2 years and 3 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
Outcome measures
| Measure |
Menitorix Group
n=290 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=100 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 0.3 µg/mL [prior to vaccination] (N=283, 96)
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 0.3 µg/mL [1 month post-vaccination] (N=290,100)
|
290 Subjects
|
100 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 0.3 µg/mL [1 year post-vaccination] (N=250, 91)
|
95 Subjects
|
33 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 0.3 µg/mL [2 years post-vaccination] (N=233,84)
|
47 Subjects
|
17 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 0.3 µg/mL [3 years post-vaccination] (N=230,79)
|
24 Subjects
|
8 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 2.0 µg/mL [1 month post-vaccination] (N=290,100)
|
289 Subjects
|
96 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 2.0 µg/mL [prior to vaccination] (N=283, 96)
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 2.0 µg/mL [1 year post-vaccination] (N=250, 91)
|
6 Subjects
|
0 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 2.0 µg/mL [2 years post-vaccination] (N=233,84)
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
≥ 2.0 µg/mL [3 years post-vaccination] (N=230,79)
|
1 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Prior to, 1 month, 1 year, 2 years and 3 years after vaccinationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
Concentrations given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Menitorix Group
n=290 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=100 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
1 month after vaccination (N=290,100)
|
18.69 micrograms per milliliter (µg/mL)
Interval 17.1 to 20.42
|
7.95 micrograms per milliliter (µg/mL)
Interval 6.95 to 9.08
|
|
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
1 year after vaccination (N=250, 91)
|
NA micrograms per milliliter (µg/mL)
Interval to 0.3
Lower limits of 95% confidence interval not reliable because of deviation from log normal distribution (large number of imputed values)
|
NA micrograms per milliliter (µg/mL)
Values were below the assay cut-off at this timepoint of 0.3 µg/mL.
|
|
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
2 years after vaccination (N= 233, 84)
|
0.2 micrograms per milliliter (µg/mL)
Lower and Upper limits of 95% confidence interval not reliable because of deviation from log normal distribution (large number of imputed values)
|
0.2 micrograms per milliliter (µg/mL)
Lower and Upper limits of 95% confidence interval not reliable because of deviation from log normal distribution (large number of imputed values)
|
|
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
3 years after vaccination (N= 230, 79)
|
NA micrograms per milliliter (µg/mL)
Values were below the assay cutoff at this timepoint of 0.3 μg/mL.
|
NA micrograms per milliliter (µg/mL)
Values were below the assay cutoff at this timepoint of 0.3 μg/mL.
|
|
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Prior to vaccination (N=283, 96)
|
NA micrograms per milliliter (µg/mL)
Values were below the assay cut-off at this timepoint of 0.3 µg/mL.
|
NA micrograms per milliliter (µg/mL)
Values were below the assay cut-off at this timepoint of 0.3 µg/mL.
|
SECONDARY outcome
Timeframe: Within 4 days (Day 0 -Day 3) after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite.
Outcome measures
| Measure |
Menitorix Group
n=324 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=109 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Pain
|
91 Subjects
|
42 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Redness
|
146 Subjects
|
64 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Swelling
|
78 Subjects
|
41 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Drowsiness
|
102 Subjects
|
40 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Fever
|
76 Subjects
|
30 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Irritabily
|
154 Subjects
|
69 Subjects
|
|
Number of Subjects Reporting Solicited Local and General Symptoms
Loss of appetite
|
102 Subjects
|
40 Subjects
|
SECONDARY outcome
Timeframe: Within 31 days (Day 0 - Day 30) after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.
Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Outcome measures
| Measure |
Menitorix Group
n=324 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=109 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Symptoms
|
217 Subjects
|
81 Subjects
|
SECONDARY outcome
Timeframe: Throughout the entire study period (up to year 5)Population: Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study.
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually.
Outcome measures
| Measure |
Menitorix Group
n=324 Participants
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=109 Participants
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
Vaccination Phase (N=324, 109)
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
Until year 5 (N=295, 100)
|
0 Subjects
|
0 Subjects
|
Adverse Events
Menitorix Group
Serious events: 4 serious events
Other events: 293 other events
Deaths: 0 deaths
Meningitec + Hiberix Group
Serious events: 2 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menitorix Group
n=324 participants at risk
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=109 participants at risk
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.92%
1/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Psychiatric disorders
Breath holding
|
0.31%
1/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.00%
0/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Nervous system disorders
Convulsion
|
0.31%
1/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.00%
0/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Infections and infestations
Croup infectious
|
0.31%
1/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.00%
0/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Infections and infestations
Gastroenteritis
|
0.31%
1/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.00%
0/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.92%
1/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Pyrexia
|
0.00%
0/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.92%
1/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.92%
1/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.31%
1/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
0.00%
0/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
Other adverse events
| Measure |
Menitorix Group
n=324 participants at risk
Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
Meningitec + Hiberix Group
n=109 participants at risk
Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
54/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
11.9%
13/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Gastrointestinal disorders
Teething
|
12.3%
40/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
13.8%
15/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Pyrexia
|
11.4%
37/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
11.9%
13/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
24/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
15.6%
17/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
25/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
7.3%
8/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
22/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
8.3%
9/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.2%
17/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
2.8%
3/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Injection site reaction
|
2.2%
7/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
9.2%
10/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.8%
9/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
8.3%
9/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Irritability
|
47.5%
154/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
63.3%
69/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Pain
|
28.1%
91/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
38.5%
42/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Redness
|
45.1%
146/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
58.7%
64/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Swelling
|
24.1%
78/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
37.6%
41/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Drowsiness
|
31.5%
102/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
36.7%
40/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Fever (above or equal to 38 degrees Celsius)
|
23.5%
76/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
27.5%
30/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
|
General disorders
Loss of appetite
|
31.5%
102/324 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
36.7%
40/109 • Up to Year 5 for Serious Adverse Events. Within 31 days after vaccination for Other Adverse Events that were not systematically assessed. Within 4 days after vaccination for Other Adverse Events that were systematically assessed.
For long-term persistence (Years 1 to 5), only SAEs that are determined by the investigator as causally related to vaccination will be described individually. No SAEs related to vaccination were reported between the end of the vaccination phase up to Year 5.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER